NCT06510842

Lumbar Drainage of Intraventricular Hemorrhage

Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 354 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.

Conditions

• Intraventricular Hemorrhage
• Lumbar Drainage
• External Ventricular Drainage

Interventions

Type	Name	Description
OTHER	External drainage of intraventricular hemorrhage	An EVD is required to be eligible for the DRAIN IVH study. Weaning from the EVD is at the discretion of the local investigators. Imaging is at discretion of local investigators. Use, timing and frequency of fibrinolysis via EVD is at local discretion, too.

Timeline

• Start date: 2025-01-16
• Primary completion: 2029-01-01
• Completion: 2029-07-01
• First posted: 2024-07-19
• Last updated: 2026-01-28

Locations

12 sites across 1 country: Germany